The Recall Desk
SevereFDA (Devices)·Z-1227-2022·Announced 2022-06-15

Ventilator Backup Battery Failure Recalled by GE Healthcare Worldwide

GE Healthcare is recalling backup batteries for ventilators used in critical care. The batteries may not provide sufficient backup power when disconnected from AC, potentially causing unexpected device shutdown.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification indicates a reasonable probability of serious adverse health consequences. Although no illnesses or deaths have been reported, the defect affects critical life-support equipment and mandates a minimum severity score of 4 per the rubric.

Plain-English summary

GE Healthcare, LLC is recalling replacement backup batteries for CARESCAPE R860, Engström Carestation, and Engström PRO Ventilators that were distributed on or after April 1, 2019. Approximately 88,379 batteries are affected.

The batteries have insufficient backup power when the ventilator is not connected to AC mains power supply. This can result in premature shutdown of the ventilator.

These batteries were distributed nationwide in the United States and to healthcare facilities in multiple countries worldwide. Customers with affected batteries should contact GE Healthcare for replacement units. Healthcare providers should verify proper functionality of their ventilators before patient use.

The recalled product

Product
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Respiratory Equipment
Hazard
  • backup-power-failure
  • device-shutdown

Distribution

Distributed nationwide across the United States.

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